Kornimate/medical-research-clean huggingface dataset:
towards telemonitoring in immune-mediated inflammatory diseases: implementation of a mixed attention model (imidoc)

Conditions: Telemedicine; Telehealth; eHealth; Rheumatic Diseases; Arthritis, Rheumatoid; Spondylarthritis

Summary: the main objective is to evaluate the implementation of a hybrid care model called the mixed attention model (mam) in clinical practice and to evaluate whether its implementation improves clinical outcomes compared to conventional follow-up. this is a multicenter prospective observational study involving 360 patients with rheumatoid arthritis (ra) and spondylarthritis (spa) from five spanish hospitals. patients will be followed-up by the mam protocol, which is a care model that incorporates the use of digital tool consisting of a mobile application (app) that patients can use at home and that professionals can review asynchronously to detect incidents and to follow their patients; clinical evolution between face-to-face visits. another group of patients, whose follow-up will be conducted in accordance with a traditional face-to-face care model, will be assessed as the control group. sociodemographic characteristics, treatments, laboratory parameters, assessment of tender and swollen joints, visual analogue scale for pain and electronic patient reported outcome reports (epros) will be collected for all subjects. in the mam group, these items will be self-assessed both by the mobile app and during face-to-face visits with rheumatologist, who will do the same for patients included in the traditional care model. patients will be able to report any incidence related to their disease or treatment through the mobile app.


Eligibility criteria:
inclusion criteria: * clinical diagnosis with rheumatoid arthritis or spondylarthritis * treatment with biologic or targeted disease modifying antirheumatic drugs. * ability to use smartphone. exclusion criteria: * only patients with conditions that hinder or prevent the use of a mobile application (blindness, mental retardation, dementia, digitalfilliteracy).
a+ asthma early intervention in asthma management

Conditions: Asthma

Summary: this project will evaluate the effectiveness of a head start-based early intervention for designed to improve asthma management skill and practices of parents, pre-school children and head start staff.

background: while increased asthma morbidity and mortality have been observed across all ethnicities, results from several studies have found that asthma morbidity has increased disproportionately in low-income african american children. elementary school-based asthma education programs have shown promise in improving asthma management, and reducing asthma morbidity in this high-risk population, however, the fastest growing asthma risk is associated with children young than six. by elementary age many parents and children with asthma have well-established patterns of inappropriate asthma management that may be difficult to change. to date, no research has examined the impact of early intervention for asthma management in low-income, high-risk children. design narrative: head start sites will be randomized to either a minimal intervention control group or the a+ asthma early intervention program designed to educate and assist head start teachers and family service coordinators to: optimize classroom management of asthma, educate, facilitate and reinforce appropriate parental medical and behavioral management of asthma, and instruct, model and reinforce early asthma knowledge and age-appropriate skills for preschool age children. the primary outcome that the study was designed to evaluate head start absences/days enrolled, determined by review of head start attendance records. the secondary outcomes specified in the protocol are health care utilization (emergency department visits, hospitalizations, primary care visits), asthma symptoms (restricted activity, symptom-free days, day and nighttime symptoms), asthma medications, parents' asthma-related quality of life, and parent, child and teacher asthma knowledge and management practices. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
children aged 3 and 4 years who have asthma that is currently active
a dose finding study of cpg in patients with chronic lymphocytic leukemia who have been previously treated

Conditions: Chronic Lymphocytic Leukemia

Summary: * cpg has the potential to stimulate the immune system * this study will evaluate the safety of cpg given sub-q or iv * purpose is to measure biological changes in cll cells after receiving cpg


Eligibility criteria:
inclusion criteria: * diagnosis of cll * cll previously treated * hemoglobin \>/= 10 * platelets \>/= 50,000 * neutrophils \>= 1,000 - exclusion criteria: * patients with brain mets * patients with autoimmune disease * patients on corticosteroids or immunosuppressants * patients with uncontrolled intercurrent illness * pregnant women * hiv patients receiving combination anti-retroviral therapy

Keywords: cpg 7909 cll
xarelto for prevention of stroke in patients with atrial fibrillation in latinamerica and emea region

Conditions: Atrial Fibrillation

Summary: this international study is a prospective noninterventional observational cohort study of patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. patients will be followed up for 1 year or until 30 days after end of rivaroxaban therapy in case of therapy was discontinued earlier than 12 months. serious adverse events will be followed up adequately. laboratory values (e.g., hb, hct, haemoccult) should be documented for each point in time they were measured.


Eligibility criteria:
inclusion criteria: * female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-cns systemic embolism, and who consent to participate in the study. exclusion criteria:

Keywords: atrial fibrillation observation stroke embolism
an evaluation of a culturally- and linguistically-appropriate online diet program for u.s hispanics

Conditions: Obesity

Summary: the purpose of this study is to conduct a randomized trial to rigorously test the efficacy of the midieta ehealth portal for weight loss among overweight, though otherwise healthy, members of the hispanic community, many of whom may be members of collaborating managed care organizations.

obesity is a major and growing problem among u.s. hispanics with serious implications for diabetes and other chronic disease risks. current trends among youth suggest that disparities in obesity between minorities and non-hispanic whites will amplify. reducing such health disparities is a priority for federal, state and local governmental bodies and communities. attaining these objectives will require interventions that are culturally- and linguistically appropriate. u.s. healthcare providers, however, have few culturally-appropriate tools and inadequate numbers of bilingual, trained healthcare professionals to address these challenges. a culturally-appropriate weight-management portal, supported by bilingual latina dietitians available for remote email counseling, offers an attractive mechanism for efficiently serving the underserved. midieta/mydiet is the leading online diet, fitness and weight management portal for u.s. hispanic/latinos. midieta is bilingual (spanish/english), based on latino foods \& habits and already available through dozens of media, hospital, and health plan websites. thousands of hispanics access midieta each week. tommy thompson recently selected midieta as one of the "20 most innovative health promotion and disease prevention applications" in the u.s.

Eligibility criteria:
inclusion criteria: * women and men of hispanic/latino origin born in mexico, central or south america, the caribbean, spain or the united states * between 18 and 75 years of age * bmi \>/= 24.85 * otherwise "healthy" individuals (lack of major medical/psychiatric/ or chronic problems/disease - with the exception of type 2 diabetes and controlled hypertension) * not participating in other weight loss treatment programs and not planning on it for at least 12-16 more months * internet access at least once per week * the participant has the ability to engage in at least light activity (walking, etc) exclusion criteria: * the participant has a continuous history of major medical or psychiatric problems (requiring continuous medication and/or close physician supervision) * diagnosis with type 1 diabetes * the participant is pregnant or planning a pregnancy within the next 16 months * the participant is unable to participate in any exercise regimen * the participant is currently participating in midieta * the participant is currently participating in other weight loss programs or plans to in the next 12-16 months

Keywords: obesity overweight hispanics online weight loss
a prospective, interventional study assessing response to cytarabine, daunorubicin and etoposide (ade) for first relapse of paediatric acute myeloid leukemia

Conditions: Acute Myeloid Leukemia, in Relapse

Summary: one-third to one-half of patients with aml relapse and in general relapsed aml patients have a poor prognosis. the treatment of relapsed aml consists of induction chemotherapy followed by allogenic stem cell transplant (asct). however, at present there is no standard salvage chemotherapy regimen for relapsed aml, as no study has shown any one regimen to be significantly superior. anthracyclines, fludarabine, etoposide and cytarabineare active agents in amland have been used as monotherapy and in combination in refractory and relapsed aml patients. according to previous studies the present cr rate of different regimens ranges from 50-70%. a retrospective analysis (unpublished) conducted at irch, aiims on relapsed aml patients treated with ade (cytarabine, daunorubicin and etoposide) chemotherapy showed the cr rates of approximately 70%. therefore, we have planned this study to test the efficacy and toxicity of ade induction chemotherapy in relapsed aml patients in a prospective manner.


Eligibility criteria:
inclusion criteria: 1. either gender with age ≤18 years at initial diagnosis 2. aml(non-m3) patients at first relapse (medullary) exclusion criteria: 1. primary refractory aml \&secondary aml 2. more than or equal to 2 relapses of aml 3. symptomatic cardiac dysfunction (ctcae grade 3 or 4) 4. active infection(pneumonia etc.) 5. any other organ dysfunction (ctcae grade 4) 6. patients not willing to consent for the study
blood sample collection in subjects with pulmonary nodules or ct suspicion of lung cancer or pathologically diagnosed lung cancer

Conditions: Lung Cancer (Diagnosis)

Summary: the primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens for use in assessing new biomarkers for the detection of neoplasms of the lung. subjects will be men and women, 35 years of age and older, with a ct confirmed nodule measuring 6-30 mm.

subjects with pulmonary nodules, a suspicion of lung cancer or pathologically confirmed, untreated lung cancer will be enrolled. blood samples will be collected at enrollment and may be collected at 12 months for subjects with pulmonary nodules. radiological and pathological data will be collected to confirm a cancer diagnosis or up to 2 years to assess nodule resolution.

Eligibility criteria:
inclusion criteria: * all subjects: 1. subject is male or female, 35 years of age or older. 2. subject has at least one ct confirmed 6-30 mm nodule. 3. subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator. suspicion of cancer subjects: 4. subject has ct suspicion of lung cancer and is scheduled for biopsy or other diagnostic procedure. pathologically confirmed cancer subjects: 4. subject has pathologically confirmed lung cancer and is treatment naïve. pulmonary nodule subjects: 4. subject has a recent (within 90 days of enrollment) ct radiological diagnosis of pulmonary nodule(s) without a scheduled biopsy/diagnostic procedure (other than ct or pet/ct). exclusion criteria: * all subjects 1. ct with iv contrast within 1 day \[or 24 hours\] of blood collection. 2. prior history of cancer within the past 5 years except for non-melanoma skin cancer. for subjects with suspicion of lung cancer who may have a concurrent work-up for another primary cancer, the non-lung cancer primary must be ruled out prior to enrollment. 3. prior removal of the lung, excluding percutaneous lung biopsy. 4. treatment (e.g., surgical resection, radiofrequency ablation) for pulmonary nodules prior to blood sample collection for this trial. 5. individual has a condition the investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk. pathologically confirmed cancer subjects: 6. biopsy within 7 days prior to blood collection. 7. unresolved bleeding as a result of biopsy at the time of enrollment.
hypoallergenicity of a hydrolyzed protein infant formula

Conditions: Cow's Milk Allergy

Summary: study to demonstrate hypoallergenicity of a hydrolysed protein infant formula in a population of children with confirmed cow's milk allergy.

the study consists of a double-blind, placebo-controlled food challenge, followed by a single arm open challenge.

Eligibility criteria:
inclusion criteria: 1. infants and children aged up to 3 years. 2. diagnosed with cow's milk allergy (or re-confirmed), within two months prior to the study (challenge day #1), by: 1. physician-supervised double-blind oral food challenge; or 2. physician-supervised open oral food challenge that elicited objective immediate allergic reactions; or 3. report of convincing allergic reaction to cow's milk or a milk-containing food product, in conjunction with presence of milk-specific serum immunoglobuline e (ige) level \> 0.7 kilounit per liter (u/l) or by skin prick test (wheal size ≥ 3mm). 3. willing to switch to a different hypoallergenic formula 4. on elimination diet (commercially available, hypoallergenic infant formula ) and free of clinical symptoms, or with controlled stable symptoms, for at least one week preceding the study (challenge day #1). 5. expected minimal consumption of 144ml of test product/day during the open challenge. 6. written informed consent provided by parents/guardians, according to local law. exclusion criteria: 1. infants/children who are more suitable to use aaf as first-line formula, including but not limited to those with high risk of anaphylaxis (prior history of anaphylaxis and currently not using ehf) or severe forms of non-ige-mediated cma such as eosinophilic oesophagitis, enteropathies, or food protein-induced enterocolitis syndrome (fpies). 2. diagnosis or known allergy to any of the ingredients in the test product. 3. congenital anomalies which will interfere with oral feeding or gastrointestinal tract, other chronic diseases (including but not limited to cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological and endocrine disease), major gastrointestinal disease/abnormalities, or any other medical condition that could interfere with the identification of allergic reactions. 4. (twin / triplet) sibling of an infant/child already participating in the study. 5. investigator's uncertainty about the willingness or ability of the subject and his/her parents to comply with the protocol requirements. 6. participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study. 7. employees and/or children/family members or relatives of employees of nutricia research or the participating study sites.

Keywords: infant formula hypoallergenicity
intra-arterial measurement of po2 in walking induced transient hack profiles

Conditions: Claudication

Summary: confirm with invasive measurement the presence of a walking-induced transient hack (with) profile

arterial po2 and body temperature measurements during exercise

Eligibility criteria:
inclusion criteria: * walking induced transient hack (with) tcpo2 profile exclusion criteria: * rejection by patient
kinesio® tex taping for post total knee replacement patients

Conditions: Knee Osteoarthritis

Summary: this study is designed to better understand the effect of kinesio taping applied using the neurotaping technique on patients who underwent total knee arthroplasty surgery. patients will be randomized in two groups: in the first group patients will follow a protocol of usual rehabilitation, while the second group will do the same but add the kinesio taping application. main outcome will be the effect on edema, secondary outcome the effect on functionality after 13 days post surgery.


Eligibility criteria:
inclusion criteria: * program of total knee replacement; * signing and accepting informed consent. exclusion criteria: * pre-operative barthel index score \< 70; * program of revision of total knee replacement; * grade iii-iv heart failure; * grade iii-iv kidney failure; * hypersensitive skin or intolerance to taping; * active cutaneous infection or open skin lesion on the sites of taping positioning; * body mass index \> 34,9; * pregnant women; * not accepting informed consent; * impossibility to follow usual rehabilitation treatment.

Keywords: knee osteoarthritis total knee arthroplasty kinesiotaping neuro taping rehabilitation
diagnostic and prognostic value of pten expression in functional and pathological endometrial biopsies

Conditions: Endometrial Hyperplasia; Endometrial Adenocarcinoma

Summary: endometrial hyperplasia may progress to endometrial adenocarcinoma. the exact possibility of such progression is not determined. there a need to detect biological markers that can help in detecting high risk cases of patients with endometrial hyperplasia that may progress to endometrial adenocarcinoma. pten is a tumor suppressor gene that inhibit cell migration, proliferation and may induce apoptosis in damaged cells. variable expression of pten in functional, hyperplastic and neoplastic endometrial tissues may be of great help in detecting cases of hyperplasia that may progress to endometrial adenocarcinoma.

adenocarcinoma of the endometrium is the most prevalent invasive tumor of female genital tract. endometrial carcinoma is divided to 2 different types as regards to genitical and phenotypical features, type i endometrial carcinoma represents more than three quarters of all cases. type i is inevitably preceded by hyperplastic changes in the endometrium. however, the malignant potential of endometrial hyperplasia to carcinoma is markedly variable and subjected to interobserver variations. determine of novel biological markers for detection of precancerous endometrial hyperplasia that may proceed to endometrial adenocarcinoma is a must. pten is a tumor suppressor gene. it inhibits cell mitosis and migration. pten induce the damaged cells to pass in apoptosis. low levels of pten expression noted in many human malignancies as melanoma, mammary and ovarian carcinomas. the aim of this study is to evaluate the expression of pten (by immunohistochemistry) in different endometrial biological conditions as endometrial hyperplasia and primary endometrial adenocarcinoma specimens, and correlate that expression to pten expression in physiological endometrial specimens.

Eligibility criteria:
inclusion criteria: * all cases of endometrial biopsies and hystrectomy specimens diagnosed as endometrial hyperplasia and/or primary endometrial adenocarcinoma. * all cases of normal endometrium obtained from hystrectomy specimens due to other pathological conditions as prolapsed uteri, uterine leiomyoma and adenomyosis. exclusion criteria: * autolysed samples, very tiny specimens cervical tissues and specimens with histological picture of endometritis.

Keywords: pten. endometrial hyperplasia. endometrial carcinoma
clinical trial to demonstrate the efficacy of a dietary supplement in decreasing cardiovascular risk

Conditions: Low-Moderate Hypercholesterolemia

Summary: this clinical trial seeks to verify the efficacy of a red rice yeast dietary supplement in the decrease of cardiovascular risk, by assessing variables related with cardiovascular risk as levels of cholesterol, triglycerides and transaminases among other, in two groups of participants that will be taking either the dietary supplement or a placebo during a six months period.


Eligibility criteria:
inclusion criteria: * 18 years old or older * body mass index (bmi) between 18.5 y 29.9. * ldl-c levels between 100mg/dl and 160mg/dl * 10 year estimated cardiovascular risk assessed by the ascvd less than 20% * accepts to participate and sings informed consent. exclusion criteria: * patients with history of cardiovascular diseases. * patients with secondary hyperlipidemia caused by diabetes mellitus, or kidney, liver or thyroid diseases. * patients with muscle diseases * patients undergoing pharmacological treatment with any of the following: lipid lowering agents, antifungal, macrolides, or hormone replacement therapy in progress or during the last 2 months. * patients with proven intolerance with the components present in the dietary supplement. * patients with any other concomitant disease that to the researcher's criteria are not susceptible to participate in the study. * woman that are pregnant, in breastfeeding period or with a possibility of starting a pregnancy.
assessment of the preoperative risk factors for the development of post-lasik ectasia

Conditions: Lasik Eye Surgery

Summary: : laser-assisted in situ keratomileusis (lasik) is one of the most widely performed refractive surgeries, offering effective and long-lasting correction for visual refractive errors. while lasik has a high success rate and is generally safe, post-lasik ectasia remains a rare but serious complication that compromises visual outcomes. several risk factors for post-lasik ectasia have been identified. the aim of the present study is to determine the preoperative risk factors for the development of post-lasik ectasia.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of corneal ectasia was made by progressive central or inferior corneal steepening, increased myopia and/or astigmatism, and decreased visual acuity exclusion criteria: * subjects who had glaucoma diagnosis, other corneal surgeries (other than lasik), and central corneal opacity